An interventional study of Transcranial alternating current stimulation (TACS) and Sham TACS in Delirium, sponsored by Kuopio University Hospital. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by Kuopio University Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if transcranial alternating current stimulation can shorten the duration of delirium in intensive care setting. The main question it aims to answer:
Researchers will compare experimental treatment to sham.
Participants will receive experimental or sham treatment on maximum of two days depending on their delirium status. Duration of delirium is recorded and reported as "days alive and free of delirium".
Delirium is an acute-onset brain dysfunction related to extensive surgery or critical illness that leads to altered mental status and cognitive deficits. Delirium is associated with an increased length of stay in the ICU, cost of care, excessive mortality, and long-term cognitive and functional impairment. Although numerous prophylactic methods have been proposed, currently, no pharmacological or non-pharmacological methods are clinically effective. Patients with delirium have altered electroencephalography (EEG) findings among which most important are general slowing of EEG frequencies and dysconnectivity. Faster EEG frequencies, especially alpha-, beta-, and gamma-bands, are correlated with higher cognitive functions, such as memory and orientation. Transcranial alternating current stimulation (TACS) is a novel, noninvasive brain stimulation technology that cab modulate EEG frequencies by entraining of endogenous brain oscillations in response to exogenous stimuli. TACS has been shown to improve episodic memory, orientation, and cholinergic dysfunction in patients with Alzheimer's disease. TACS also increases alpha and gamma frequencies in EEG, and an increase in these frequencies is associated with the improvement of clinical symptoms. TACS has been shown to target key components of delirium pathophysiology, such as slowing of EEG frequencies and cholinergic dysfunction. Thus, we hypothesized that TACS could shorten the duration of delirium and decrease cognitive decline. We aim to test this hypothesis in a double-blind randomized trial and assess the effect of TACS on duration of delirium, EEG, biomarkers and long-term cognition.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 78 is below the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Kuopio University Hospital is the lead sponsor of 132 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental intervention is alternating sinusoidal current at frequency of 40 Hz applied for 60 min through a pair of saline-soaked surface sponge electrodes. One electrode is placed with the center over Pz position according to the 10-20 international EEG coordinates (an area overlying the medial parietal cortex and the precuneus) and the other over the right deltoid muscle.
Device: Transcranial alternating current stimulation (TACS)
The same electrodes are connected to the patient as in trial intervention. In sham treatment, a few seconds of actual current is provided and then the device automatically turns off. This is to ensure that patients cannot distinguish between real and sham treatments based on possible tingling of skin when starting the electrical current.
Device: Sham TACS
Transcranial alternating sinusoidal current at frequency of 40 Hz applied for 60 min through a pair of saline-soaked surface sponge electrodes.
Sham treatment with few seconds of actual electrical current and same electrode configuration
Days alive and free of delirium or coma
Days alive and free of delirium or coma
Time frame: 28 days
Biomarker profile
Concentrations of neurofilament light (nfl), glial fibrillary acid (gfap) and plasma tau (ptau) on days 0, 2 and 4
Time frame: 4 days
EEG changes
EEG Spectral power
Time frame: 2 days
CERAD
CERAD test (Consortium to Establish a Registry for Alzheimer's Disease)
Time frame: 3 and 12 months
TMT test A
Trail Making Test A
Time frame: 3 and 12 months
TMT test B
Trail Making Test B
Time frame: 3 and 12 months
Short latency inhibition
Measurement of brain cholinergic function by short latency inhibition with transcranial magnetic stimulation
Time frame: 3 and 12 months
Plan to share: No
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Kuopio University Hospital